VIRGO PANCO KIT— 510(k) K973824

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K973824 for VIRGO PANCO KIT, Substantially Equivalent on 1997-11-13. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Hemagen Diagnostics, Inc.
Product code
Code MOB
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
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